Effectiveness of high-intensity inspiratory muscle training, and resistance and aerobic exercise for cardiovascular health in chronic obstructive pulmonary disease (HIRAC-COPD): a randomized controlled trial protocol.

Autor: Yu B; Institute for Disaster Management and Reconstruction, Sichuan University-The Hongkong Polytechnic University, Chengdu, 610207, China.; West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China., Liu W; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Hu Y; Department of Rehabilitation Medicine, West China Tianfu Hospital, Sichuan University, Chengdu, 610213, China., Huang Y; Chengdu Eastern New Area Public Health Center, Chengdu, 641418, China., Dai Q; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Yang Y; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Fu C; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Zeng Z; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Li L; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Yang B; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Lei Z; Chengdu East New Area Second People's Hospital, Chengdu, 641421, China., Fan Y; West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China., Li Y; School of Geography, University of Leeds, Leeds, LS2 9JT, UK., Wu J; Deep Underground Space Medical Center, West China Hospital, Sichuan University, Chengdu, 610041, China., Zhu J; West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China., Yu P; West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China., Yang J; West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China., Zuo H; West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China. zuohaojiang@scu.edu.cn., Jia P; School of Resource and Environmental Sciences, Wuhan University, Wuhan, 430079, China. jiapengff@hotmail.com.; School of Public Health, Wuhan University, Wuhan, 430071, China. jiapengff@hotmail.com.; Renmin Hospital, Wuhan University, Wuhan, 430060, China. jiapengff@hotmail.com.; International Institute of Spatial Lifecourse Health (ISLE), Wuhan University, Wuhan, 430079, China. jiapengff@hotmail.com., Yang S; West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China. yangsj@scu.edu.cn.; School of Public Health, Wuhan University, Wuhan, 430071, China. yangsj@scu.edu.cn.
Jazyk: angličtina
Zdroj: BMC pulmonary medicine [BMC Pulm Med] 2024 Dec 20; Vol. 24 (1), pp. 627. Date of Electronic Publication: 2024 Dec 20.
DOI: 10.1186/s12890-024-03385-z
Abstrakt: Background: Cardiovascular diseases are among the most common and clinically significant comorbidities of chronic obstructive pulmonary disease (COPD). Exercise has been shown to reduce the risk of cardiovascular diseases, and high-intensity inspiratory muscle training (H-IMT) has emerged as a promising intervention for improving arterial stiffness in individuals with COPD. Yet, there is limited evidence from randomized controlled trials (RCTs) regarding the impact of H-IMT alone or in combination with exercise on reducing arterial stiffness in COPD. We designed a three-arm RCT to evaluate the effectiveness of H-IMT, both alone and in combination with exercise, in reducing brachial-ankle pulse wave velocity (baPWV) in individuals with stable COPD within a community setting.
Methods: This is a three-arm, parallel-group, assessor-blinded, randomized controlled trial with an eight-week intervention period and a 24-week follow-up. The trial will recruit a total of at least 162 participants with stable COPD. All participants will undergo arterial stiffness assessment using an atherosclerosis detector. Eligible participants will then be randomized into either a control group or one of two intervention groups: an H-IMT group combined with aerobic and resistance trainin, or an H-IMT group alone. The primary outcome is the baPWV at eight weeks. Secondary outcomes include baPWV at 4, 16, and 32 weeks, along with self-reported lifestyle factors, sleep quality, mental health outcomes, self-efficacy, implicit health attitudes, quality of life, and clinical outcomes at 4, 8, 16, and 32 weeks. The main analysis will follow the intention-to-treat principle, with the difference in outcome between groups analyzed using multi-level regression at eight weeks.
Discussion: This study will provide evidence on the effects of H-IMT and combined exercise interventions for individuals with COPD in a community setting, offering insights into the use of integrated approaches to enhance cardiovascular health among community-dwelling residents.
Trial Registration Number: ChiCTR2400085483. Date of registration: June 7, 2024. https://www.chictr.org.cn/index.aspx .
Competing Interests: Declarations. Ethics approval and consent to participate: The protocol was approved by the Ethics Committee of the West China School of Public Health and the West China Fourth Hospital, Sichuan University (Gwll2024146). All individuals will voluntarily participate in this study and provide informed consent before enrollment. Participants will be informed that they have the right to withdraw from the study without any repercussion. The study will adhere to the Declaration of Helsinki. Consent for publication: All authors reviewed the final protocol and approved submission for publication. Competing interests: The authors declare no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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